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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Recall Number Z-0977-2013
Classification Class II
Code Info Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.
Product Distributed Qty 3 units
Reason For Recall An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

Event Detail

Event Id 64112
Product Type Devices
Status Ongoing
Recalling Firm Mindray DS USA, Inc. d.b.a. Mindray North America
City Mahwah
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the states of NC and TX.
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